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Regulatory Affairs Senior Associate/Consultant - Combination Products

Parexel International Corporation

USA - Any Region - Home Based

Excellent opportunity for a “cradle to crypt” Medical Device Regulatory professional to share their expertise with multiple clients with innovative technologies OR an excellent opportunity for a highly motivated Medical Device Regulatory professional to gain "cradle to crypt" exposure and grow their career!

Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product Consultant to join the team and, based upon the individual's experience, the team is open to a highly motivated Senior Regulatory Affairs Associate with a passion and desire to build upon their foundation of combination product experience or a combination product SME who wants to partner with our clients in the very early stages of product development, use their expertise to help our clients develop their strategies, guide them along the regulatory pathway, and maintain post approval technical files.

Dependent upon previous experience, you may lead or support some/all of the following:

• Ensure global approaches to the device regulatory strategy of Drug-Device Combination products and Medical Devices with particular focus on the requirements in the US, EU, Japan and China.

• Lead and/or support Drug-Device Combination products and Medical Devices development and global filing activities from a regulatory standpoint from initial product concept through the product life cycle e.g. clinical submissions, technical files, marketing applications, response to questions, post-approval submissions and Agency Briefing Documents.

• Understand and interpret global regulations/ guidelines relating to Drug-Device Combination products and Medical Devices.

• Convey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.

• Act as an advisor and partner with functional units on the implementation of Drug-Device Combination and Medical Device regulatory requirements.

• Provide device-related advice on data management systems QualificationsAt least 2+ years experience experience in an industry-related Regulatory Affairs role gained from the Pharmaceutical/Biotechnology, CRO, or Consulting industries for a Senior Regulatory Affairs Associate role; 4+ years relevant experience for a Regulatory Affairs Consultant role; 7-10+ years relevant experience for a Senior Regulatory Affairs Consultant A depth of medical device expertise as related to combination products with experience in regulatory strategy/process/writing. Past digital health or software as a medical device experience is a plus Previous experience with Class II/III devices Previous experience with off the shelf devices and new devices (end to end) Education - Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline; Advanced Degree Preferred Language Skills - At least fluent vocal and written English

When appropriate, the ability to travel up to 20% internationally and/or domestically may be required

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2022-01-20

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